ORLEPT 200MG GASTRO-RESISTANT TABLETS

Transcript

PACKAGE LEAFLET INFORMATION FOR THE USER
Orlept® 200mg and 500mg Gastro-Resistant Tablets
Sodium valproate
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
The name of your medicine is Orlept® 200mg and 500mg Gastro-Resistant Tablets. In the
rest of this leaflet it is called Orlept® Tablets.
In this leaflet:
1. What Orlept® Tablets are and what they are used for
2. Before you take Orlept® Tablets
3. How to take Orlept® Tablets
4. Possible side effects
5. How to store Orlept® Tablets
6. Further Information
1. WHAT ORLEPT® TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in Orlept® Tablets is sodium valproate which belongs to a group of
medicines known as anticonvulsants.
These are used in the treatment of epilepsy (fits). Orlept® Tablets are used in the treatment of
all types of epilepsy.
2. BEFORE YOU TAKE ORLEPT® TABLETS
Do not take Orlept® Tablets and tell your doctor if:
 you are allergic (hypersensitive) to sodium valproate or any of the other ingredients of
Orlept® Tablets (see Section 6: Further Information)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue
 you have liver problems or you or your family have a history of liver problems
 you have a rare illness called porphyria.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Orlept® Tablets.
Take special care with Orlept® Tablets
A small number of people being treated with anti-epileptics such as sodium valproate have
had thoughts of harming or killing themselves. If at any time you have these thoughts,
immediately contact your doctor.
Check with your doctor or pharmacist before taking this medicine if:
 You have diabetes. This medicine may affect the results of urine tests
 You have kidney problems. Your doctor may give you a lower dose
 You have fits (epilepsy), brain disease or a metabolic condition affecting your brain
 You have a ‘urea cycle disorder’ where too much ammonia builds up in the body
 You have an illness called ‘systemic lupus erythematosus (SLE)’ – a disease of the
immune system which affects skin, bones, joints and internal organs

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Orlept® Tablets.
Weight gain
Taking Orlept® Tablets may make you put on weight. Talk to your doctor about how this will
affect you.
Blood tests
Your doctor may wish to do blood tests before you start taking Orlept® Tablets and during
your treatment.
Taking Orlept® Tablets with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This includes medicines you buy without a prescription, including herbal
medicines. This is because Orlept® Tablets can affect the way some other medicines work.
Also some medicines can affect the way Orlept® Tablets work.
The following medicines can increase the chance of you getting side effects, when taken
with Orlept® Tablets:
 Some medicines used for pain and inflammation (salicylates) such as aspirin
 Some other medicines used to treat fits (epilepsy) – see Section 3: “Patients taking other
medicines for ‘fits.’” This includes medicines such as Phenobarbital, primidone,
phenytoin, carbamazepine, topiramate, lamotrigine and felbamate
Orlept® Tablets may increase the effect of the following medicines:
 Medicines used for thinning the blood (such as warfarin)
 Zidovudine used to treat HIV infection
 Temozolomide used to treat cancer
 Medicines for depression
 Monoamine oxidase inhibitors (MAOI) such as moclobemide, selegiline, linezolid
 Medicines used to calm emotional and mental conditions such as diazepam and
olanzapine.
The following medicines can affect the way Orlept® Tablets work:
 Some medicines used for the prevention and treatment of malaria such as mefloquine and
chloroquine
 Cimetidine used for stomach ulcers
 Carbapenem agents (antibiotics used to treat bacterial infections) such as imipenem,
meropenem, rifampicin and erythromycin. The combination of Orlept® Tablets and
carbapenems should be avoided because it may decrease the effect of your medicine.
 Colestyramine used to lower blood fat (cholesterol) levels.
Taking Orlept® Tablets with food, drink and alcohol
Alcohol intake is not recommended during treatment.
Pregnancy and breast-feeding
Women who could become pregnant

You should not take this medicine if you are pregnant or a women of child-bearing age
unless explicitly advised by your doctor.
Before you start taking Orlept® Tablets, your doctor should discuss with you the possible
problems when it is taken in pregnancy.
 Unplanned pregnancy is not desirable in women taking Orlept® Tablets
 You should use an effective method of contraception and talk to your doctor before
planning pregnancy. Orlept® Tablets have no effect on how well the oral contraceptive
pill works.
Well before you become pregnant it is important to discuss pregnancy and epilepsy with your
doctor and, if you have one, your epilepsy specialist. This is to make sure that you and your
doctor agree that you should have Orlept® Tablets if you become pregnant.
Women taking Orlept® Tablets during pregnancy have a higher risk than other women of
having a child with an abnormality. The chance of abnormalities is increased if you are also
taking other medicines for epilepsy at the same time. These abnormalities include:
 Head and face deformities including cleft palate (a gap or depression in the lip)
 Deformities of the bones, including hip dislocation
 Malformations of the arms and legs
 Deformities of the tube from the bladder to the penis, where the opening is formed in a
different place
 Heart and blood vessel malformations, including heart defects
 Defects of the lining of the spinal cord
 An abnormality of the spinal cord called ‘Spina bifida’
 Malformations of the urethra
Women who take Orlept® Tablets during pregnancy may be more likely to have a baby with
spina bifida. Taking folic acid 5mg each day as soon as you stop contraception may
lower the risk of having a baby with spina bifida.
There is also an increased risk of other birth defects. These other defects can usually be
detected in the first 3 months of the pregnancy using routine antenatal screening blood tests
and ultrasound scans.
Pregnant mothers who take Orlept® Tablets may have babies with:
 Blood clotting problems (such as blood not clotting or not clotting very well). This may
appear as bruising or bleeding which takes a long time to stop.
 Hypoglycaemia (low blood sugar)
 Hypothyroidism (underactive thyroid gland, which can cause tiredness or weight gain).
There is an increased risk of developmental delay, particularly impaired verbal or cognitive
development (low IQ scores), and autistic disorders in children born to mothers who take
sodium valproate during pregnancy. These children may require additional educational
support.
Talk to your doctor before you stop taking Orlept® Tablets if you want to become pregnant.
Do not stop taking Orlept® Tablets suddenly, as it is likely that your fits will come back.
Women who are planning to get pregnant

If you become pregnant, think you may be pregnant or plan to become pregnant while taking
Orlept® Tablets, you must tell your doctor straight away.
 Your doctor will give you appropriate counselling and will suggest changes to your
treatment or dose
 He or she will also want to check your progress while you are pregnant
It is very important that you discuss your treatment with your doctor well before you become
pregnant.
Breast-feeding
Very little sodium valproate gets into the breast milk. However, talk to your doctor about
whether you should breast-feed your baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel sleepy when taking Orlept® Tablets. If this happens to you, do not drive or use
any tools or machines. Taking other medicines used to treat fits or calm emotional and mental
health problems may increase sleepiness.
Important information for patients on a controlled sodium diet
Orlept® 200mg Tablets contain 1.20 mmol and Orlept® 500mg Tablets contain 3.01 mmol of
sodium per dose. This needs to be taken into consideration by patients on a controlled sodium
diet.
3. HOW TO TAKE ORLEPT® TABLETS
Your doctor will decide the dose which is best for you. Always follow your doctor’s
instructions completely, and also follow any special instructions or warnings which appear on
the label which the pharmacist has put on the package. If you do not understand, or are in any
doubt, ask your doctor or pharmacist.
Unless instructed differently, take your tablets with a glass of water.
Adults
The usual adult starting dose is 600mg a day, increasing by 200mg every three days until
control of your fits is achieved. The maximum dose permitted per day is 2,500mg.
Elderly patients and patients with kidney problems
Elderly patients or patients with kidney problems may need lower doses.
Children
The dose for children will depend on their weight. This is usually 20-40mg per kg of body
weight.
Combined therapy
The dose may need to be increased if you are taking other medicines to treat your epilepsy.
If you take more Orlept® Tablets than you should
If you accidentally take too many tablets contact your doctor, pharmacist or nearest hospital
casualty department. Take this leaflet and any remaining tablets with you to show the doctor
or pharmacist.

The following effects may happen: nausea vomiting, dizziness, sleepiness, the pupils of the
eyes becoming smaller, loss of consciousness, weak muscles, poor reflexes, problems with
balance and co-ordination, difficulty breathing, headaches, fits, low blood pressure.
If you miss a dose of Orlept® Tablets
If you forget to take a dose, take another as soon as you remember. If your next dose is due
within four hours, take a single dose now and do not take the next dose. Do not take a double
dose to make up for a forgotten tablet.
Stopping Orlept® Tablets
You should continue to take Orlept® Tablets for as long as your doctor tells you to. If your
doctor advises you to stop taking Orlept® Tablets, (perhaps in order to start another medicine
for your epilepsy) this will be done gradually to maintain control of your fits. Do not stop
taking Orlept® Tablets without talking to your doctor first and never suddenly stop taking
your Orlept® Tablets if you are pregnant since this may result in fits which may harm you or
your unborn child.
4. POSSIBLE SIDE EFFECTS
Like all medicines Orlept® Tablets can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following serious side effects –
you may need urgent medical treatment:
 You have an allergic reaction. The signs may include: a rash, joint pain, fever (systemic
lupus erythematosus), swallowing or breathing problems, swelling of your lips, face,
throat or tongue. Hands, feet or genitals may also be affected. More severe allergic
reactions can lead to lymph node enlargement and possible impairment of other organs.
 Liver problems and problems of the pancreas may show as a sudden illness which may
happen in the first six months of treatment. This happens in a very small number of
people taking Orlept® Tablets. It includes feeling and being sick many times, being very
tired, sleepy and weak, stomach pain including very bad upper stomach pain, jaundice
(yellowing of the skin or whites of the eyes(, loss of appetite, swelling (especially of the
legs and feet but may include other parts of the body), worsening of your fits or a general
feeling of being unwell.
Your doctor may tell you to stop taking Orlept® Tablets immediately if you have these
symptoms.
 You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be
itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of
your feet. These could be signs of a serious allergy to the medicine called ‘erythema
multiforme.’
 Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also
flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome.’
 Severe blistering rash where layers of the skin may peel off to leave large areas of raw
exposed skin over the body. Also a feeling of being generally unwell, fever, chills and
aching muscles. This may be something called ‘Toxic epidermal necrolysis.’
 Bruising more easily and getting more infections than usual. This could be a blood
problem called ‘thrombocytopenia’. It can also be due to a fall in the number of white
blood cells, bone marrow depression or another condition that affects red blood cells,
white blood cells and platelets (pancytopenia) or how the blood clots.
 Blood clotting problems (bleeding for longer than normal), bruising or bleeding for no
reason.

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Changes in mood, loss of memory, lack of concentration and deep loss of consciousness
(coma).
Underactive thyroid gland, which may cause tiredness or weight gain (hypothyroidism).
Breathing difficulty and pain due to inflammation of the lungs (pleural effusion).

Tell your doctor as soon as possible if you have any of the following side effects:
 Changes in behaviour including being very alert, and sometimes also aggressive, hyperactive and unusual or inappropriate behaviour. This is more likely if other medicine to
treat fits such as Phenobarbital and topiramate are taken at the same time or if the Orlept®
Tablets starting dose is high or has been suddenly increased.
 Changes in the amount of ammonia in the blood.
Symptoms of this condition are being sick, problems with balance and co-ordination,
feeling lethargic or less alert.
 Feeling shaky (tremor), sleepy or unsteady when walking or jerky muscle movements
 Feeling tired or confused with loss of consciousness sometimes accompanied by
hallucinations or fits.
 Blisters with the skin flaking away.
 Rapid, uncontrollable movement of the eyes.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts
longer than a few days, or if you notice any side effects not listed in this leaflet:
 Feeling sick, stomach ache or diarrhoea, especially when starting treatment. This may be
helped by taking the tablets with food
 Fainting
 Hearing loss
 Skin problems such as rashes. These happen rarely, but more often in people also taking
lamotrigine
 Acne
 Hair loss which is usually temporary. When it grows back it may be more curly than
before
 Hair, including body or facial hair grows more than normal in women
 Skin rash caused by narrow or blocked blood vessels (vasculitis)
 Changes in women’s periods and increased hair growth in women
 Breast enlargement in men
 Swelling of the feet and legs (oedema)
 Weight gain – as your appetite may be increased
 Kidney problems, bedwetting or increased need to pass urine
 Headache
 Aggression, agitation, disturbance in attention, abnormal behaviour,
restlessness/hyperactivity, and learning disorder
 Tingling or numbness in the hands and feet
Bone disorders
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of
the bone) and fractures. Check with your doctor or pharmacist if you are on long-term
antiepileptic medication, have a history of osteoporosis, or take steroids.
Blood tests

Orlept® Tablets can change levels of liver enzymes, salts or sugars shown up on blood and
urine tests.
Male fertility
Taking Orlept® Tablets can be a contributing factor in male infertility.
Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a
few days, or if you notice any side effects not listed in this leaflet.
5. HOW TO STORE ORLEPT® TABLETS
Keep out of the reach and sight of children.
Do not take this medicine if the expiry date on the carton has passed. The expiry date refers
to the last day of that month.
Orlept® Tablets should not be taken if they show signs of deterioration such as discoloration.
Do not store above 25°C.
Store in the original container or package in order to protect from light and moisture. Do not
transfer the tablets to another container.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Orlept® Tablets contain
The active ingredient in Orlept® Tablets is sodium valproate. Each tablet contains 200mg or
500mg of the active ingredient.
The other ingredients are microcrystalline cellulose anhydrous, methylated colloidal
anhydrous silica, enzymatically hydrolysed gelatine, calcium behenate, talc, triacetin,
titanium dioxide (E171), polyethylene glycol, and methylacrylic acid copolymer.
What Orlept® Tablets look like and contents of the pack
Orlept® 200mg Gastro-Resistant Tablets are white to faintly yellowish, round, bevel edged
gastro-resistant tablets.
Orlept® 500mg Gastro-Resistant Tablets are white, oval gastro-resistant tablets.
Orlept® Tablets are available in polypropylene or polyethylene containers or glass bottles of
100 tablets and blister packs of 10, 50, 60 or 100 tablets.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13
9UF, UK.
Manufacturer: Desitin Arzneimittel, Hamburg, Germany.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of
charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name
Reference number
®
Orlept 200mg
29831/0189
Gastro-Resistant Tablets
Orlept® 500mg
29831/0190

Gastro-Resistant Tablets
This is a service provided by the Royal National Institute of Blind People.
Date of leaflet preparation: 02/2013

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.